Measure to make drugs affordable

Starting with Malaysia in 2003, many Asian countries are now taking action to promote cheaper medicines through compulsory licensing, with Indonesia being the latest case.

RECENT government actions by Indonesia and India to issue compulsory licences is extending the trend in Asia to increase access to cheaper medicines to treat serious ailments, especially HIV/AIDS, cancer and Hepatitis B.

The supply of generic medicines, either through import or local production, has been the major method of reducing prices and making the drugs affordable to more people.

When the required medicines are patented, which usually results in high prices, governments are allowed by the WTO rules to issue a compulsory licence to enable themselves or private companies to import or produce generic versions, which usually cost much less.

In 2003, Malaysia became the first developing country to issue a compulsory licence to a local firm to import drugs to treat HIV/AIDS from India.

Following this, Indonesia in 2004 issued a presidential decree enabling the production of some HIV/AIDS drugs while Thailand in 2007 issued compulsory licences for several HIV/AIDS and cancer drugs.

In March, India approved its first compulsory licence enabling a local company to produce a generic version of an anti-cancer drug, which could reduce the price of treating kidney and liver cancer from US$5,200 (RM15,600) a month (the price of the branded product) to US$160 a month (RM480) (the price of the generic product).

The latest measure was taken on Sept 3 by Indonesian President Susilo Bambang Yudhoyono who issued a decree which has the effect of a compulsory licence.

It enables local manufacturers to make, import and sell generic versions of seven patented drugs used for treating HIV/AIDS and Hepatitis B.

The decree said that in line with the urgent need to control HIV/AIDS and Hepatitis B in Indonesia, "it is necessary to continue and expand the access policies to provide access to anti-viral and anti-retroviral medicines still protected by patent".

This is the third time Indonesia has issued a set of compulsory licences.

The latest decree stated that the 2004 and 2007 decrees were no longer sufficient to implement the policies.

The compulsory licence is aimed at significantly reducing the prices of these life-saving medicines and making them accessible to thousands more Indonesian patients.

"We will ensure the availability of good quality, safe and effective generic versions of anti-retroviral and anti-viral drugs," said HM Subuh, infectious disease control director at the Indonesian Health Ministry, as quoted in The Jakarta Post on Oct 19.

According to the decree, the generic companies would have to pay a royalty of 0.5% of the net sales value of the generic drugs to the companies that own the patents such as Merck, Glaxo SmithKline, Bristol Myers Squibb, Abbott and Gilead.

The latest decree enables the supply of generic anti-retroviral products for not only better first but also second-line anti-retroviral therapy.

"With the 2012 regulation, we obviously can improve access to quality but affordable drugs," Maura Linda Sitanggang, the Health Ministry's director-general for pharmaceuticals and medical equipment, told The Jakarta Post.

"We're using this mechanism concerning public interest on the production of quality but affordable medicines to treat HIV and HBV."

The seven medicines which are the subject of the compulsory licence (known in this case as for "government use") are efavirenz, abacavir, didanosin, lopinavir+ritonavir combination, tenofovir, tenofovir+emtricitabine and tenofovir+emtricitabine+efavirenz. All the drugs are used to treat HIV/AIDS.

The drug tenofovir (brand name Viread produced by patent holder Gilead) is also used to treat Hepatitis B, which affects 13 million people in Indonesia.

It had been approved in the United States for treating HIV/AIDS in 2001 and for treating chronic Hepatitis B in 2008.

The combination drug tenofovir+emtricitabine (brand name Truvada, produced by Abbot) is taken in a single dose once a day.

It has been used to treat HIV/AIDS and in July 2012 it also became the first drug approved by the US Food and Drug Administration for use as a preventive measure, to reduce the risk of HIV infection for people at high risk, including those who may engage in sex with HIV infected patients.

In India, the patent office in March approved the country's first compulsory licence to local firm Natco Pharma to make a generic version of the cancer drug sorofenib tosylate (brand name Nexavar, produced by Bayer).

The drug is used to treat advanced kidney and liver cancer.

According to the terms of the licence, Natco would pay Bayer royalties of 6% of its net sales.

Bayer challenged the compulsory licence and on Sept 16 the Intellectual Property Appellate Board rejected its petition, ruling that "if a stay is granted it will jeopardise the interests of the public who are in need of the drug".

Other developing regions have also been making use of the compulsory licence option in the WTO's intellectual property treaty known as TRIPS.

They include Brazil and Ecuador in Latin America and Kenya, Zambia and Zimbabwe in Africa.

In 2001, the WTO's Ministerial Conference in Doha adopted a TRIPS and Public Health Declaration that asserted that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health.